System and method for generating an integrated label for container housing multi-script pouches

ABSTRACT

A system for integrating and labeling a plurality of tablet orders is described. The system comprises a graphical user interface configured to receive one or more inputs for a plurality of tablets associated with a particular patient. A software module is configured to compile the inputs into an integrated order. The system further comprises an integrated label coupled to a package containing a dose comprised of the plurality of tablets input into the graphical user interface. The integrated label indicates information about the first dose and the second dose.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present patent application claims the priority of provisional patentapplication No. 61/248,471, filed Oct. 4, 2009. The present patentapplication is also a continuation-in-part of patent application Ser.No. ______

FIELD OF THE INVENTION

The invention relates to a system and method for integrating andlabeling a plurality of tablet orders. More particularly, the inventionrelates to generating an integrated order from multiple tablet ordersand labeling a package containing an integrated order with informationabout the tablets contained in the package.

BACKGROUND

There are a variety of problems encountered by individuals takingmultiple prescription medications simultaneously. A principal concern isdetermining whether all medications have been taken in compliance withthe prescribed daily regimen. Many times this concern is compounded bythe requirement that portions of the various medications must be takenat different times during the day as well as in different amounts orquantities. For instance, some individuals, e.g., those suffering fromcertain psychological disorders, may require varying quantities of aparticular medication. For example, a patient receiving lithium mayrequire a low dosage of the medication when administration begins (e.g.,200 mg). However, as the patient's treatment continues, stronger doses(e.g., 300 mg) may be prescribed as the patient's levels are titratedupward from the starting level. Thus, a patient receiving lithium may beprescribed a single 200 mg pill for the first three days of treatment,whereafter stronger pills, or additional doses of weaker pills, areprescribed.

The fear of taking improper dosages of prescribed medications can beparticularly acute in the elderly, many of whom have some degree ofmental dementia and can easily be confused as to whether they have takenall of their mediations at the correct time. Some patients with limitedmental abilities have difficulty simply sorting their variousmedications in preparation for taking them and, thereafter, taking themin a timely manner (i.e., in compliance with their dosing cycle).Providing medications to disabled and/or incapacitated individuals canalso be a problem for caregivers, particularly those in hospitals andassisted living facilities where one caregiver may oversee themedication of many patients.

Thus, there is a need for an automated system for ordering andintegrating multiple prescription medications, whereby patients mayreceive consolidated groups of medications for administration (e.g.,usually, consumption) at prescribed dosing intervals and in prescribed,possibly varying, quantities. Such a system would decrease thepossibility of human error and provide a simple mechanism for thecorrect selection, verification, integration, packaging and delivery ofmultiple prescription medications (also referred to as “multi-scripts”).

There is also a need for a similar system for ordering and integratingmultiple non-prescription medications. Many individuals take a largevariety of vitamins, herbal supplements, herbs, oils, nutraceuticals,and other similar non-prescription medications. As with prescriptionmedications, these drugs may also require variable dosingcycles/intervals, and the advantages that accrue from an integratedorder packaged with all of the medications for a particular date anddosing interval are associated with non-prescription medications insubstantially the same proportion that they are associated withprescription medications.

There is currently a lack of packaging solutions (either front-end orback-end) that allow a patient, doctor or caregiver to generate anintegrated label for multiple medications. Thus, there is a need for asystem capable of generating an integrated label, preferably a systemcapable of operating with any front-end pharmacy solution and anyback-end automated filling robot.

The following description provides a convenient and efficient way forpatients, pharmacists, and physicians to place orders for multipletablets. The description also provides a system and method forintegration of the multiple tablet orders, whereby patients may receiveconsolidated groups of tablets for administration at prescribed dosingintervals and prescribed quantities.

SUMMARY

A system for integrating and labeling a plurality of tablet orders isdescribed. The system comprises a graphical user interface configured toreceive a first input for a first plurality of tablets associated with aparticular patient. The graphical user interface also receives a secondinput for a second plurality of tablets associated with the particularpatient. The system further comprises a software module configured tocompile the first input and the second input into an integrated order.The system also comprises an integrated label coupled to a packagecontaining a first dose from the first plurality of tablets and a seconddose from the second plurality of tablets. The integrated labelindicates information about the first dose and the second dose.

In another embodiment, the system for integrating and verifying aplurality of tablet orders comprises a secondary container configured tocontain a plurality of packages. The secondary container comprises asecondary label.

A method for integrating and labeling a plurality of tablet orders isalso described. The method comprises receiving with a graphical userinterface a first input for a first plurality of tablets associated witha particular patient. A second input for a second plurality of tabletsassociated with a particular patient is also received with the graphicaluser interface. The method further comprises compiling with a softwaremodule the first input and the second input into an integrated order.The method further comprises generating with the software module anintegrated label to couple to a package containing a first dose from thefirst plurality of tablets and a second dose from the second pluralityof tablets. The integrated label indicates information about the firstdose and the second dose.

DRAWINGS

The present invention will be more fully understood by reference to thefollowing drawings which are for illustrative, not limiting, purposes.

FIG. 1 shows an illustrative flowchart showing an overview of theprocess used to go from prescription entry to order shipment.

FIG. 2 shows a plan view of an illustrative EPPA GUI main screen.

FIG. 3 shows a plan view of an illustrative EPPA GUI for patientinformation entry.

FIG. 4 shows an illustrative flow chart demonstrating the method ofentering a new patient into the system.

FIG. 5 shows an illustrative GUI for prescription order entry.

FIG. 6 shows an illustrative flow chart depicting the process A00 forentering a new prescription order into the system.

FIG. 7 shows a flow chart of an illustrative process 700 for entering arefill Prescription.

FIG. 8 shows an illustrative process EPPA GUI for entering a newprescription, including the scanned handwritten prescription.

FIG. 9A illustrates an embodiment of the prescription input verificationprocess.

FIG. 9B shows a first view of a graphical user interface configured tofacilitate patient and order selection.

FIG. 9C shows a first view of a graphical user interface configured tofacilitate patient and order selection.

FIG. 9D shows a first view of a graphical user interface configured tofacilitate prescription input verification.

FIG. 9E shows a second view of a graphical user interface configured tofacilitate prescription input verification.

FIG. 10 shows an illustrative patient interface, including packageselection options.

FIG. 11 shows an illustrative grouping for a 30-day tablet regimen forone illustrative type of compliance packaging.

FIG. 12 shows a label area on a pre-assembled blank that is similar tothe containers shown in FIG. 11.

FIGS. 13A-13B show an isometric view of the 30-day tablet dispensingcontainer, with the top and front expanded, respectively.

FIGS. 14A-14B show a top view and a bottom view of a plurality ofillustrative sealed multiple prescription containers.

FIG. 15 shows an exploded isometric view of an illustrative multipleprescription container assembly.

FIG. 16 shows an isometric view of an illustrative multiple prescriptioncontainer assembly.

FIG. 17 shows a top plan view of a plurality of illustrative multipleprescription container assemblies, coupled to one another.

FIGS. 18A and 18B are perspective views of another embodiment of amedicament container.

FIG. 19 is a perspective view of a compliance wheel interacting with oneof a plurality of medicament containers.

FIG. 20 is a perspective view of an embodiment of an illustrative spiralpackaging system with a transparent exterior, shown with a compliancewheel and a plurality of medicament containers.

FIG. 21 is a perspective view of an illustrative spiral packagingsystem.

FIG. 22 is a perspective view of a portion of the child proof mechanismof the illustrative spiral packaging system of FIG. 21.

FIG. 23 is a front elevation view of the portion of the child proofmechanism of the illustrative spiral packaging system of FIG. 21 showingoperation of the child safety component.

FIG. 24A shows a group of seven separable pouches, wherein each pouchcomprises a plurality of different tablets.

FIG. 24B shows an exploded view of the illustrative front side of one ofthe sealed center cut pouches that is included in the strip of pouches.

FIG. 24C shows an exploded view of the illustrative back side of thepouch in FIG. 24B.

FIGS. 25A-25G show an illustrative label on the folded box.

FIG. 26 shows an illustrative GUI including a portion of the PatientInformation Booklet before printing.

FIG. 27 shows a flowchart of one illustrative embodiment of theinspection process.

DESCRIPTION

Persons of ordinary skill in the art will realize that the followingdescription is illustrative and not in any way limiting. Otherembodiments of the claimed subject matter will readily suggestthemselves to such skilled persons having the benefit of thisdisclosure. It shall be appreciated by those of ordinary skill in theart that the systems and apparatus described hereinafter may vary as toconfiguration and as to details. Additionally, the methods may vary asto details, order of the actions, or other variations without departingfrom the illustrative methods disclosed herein.

The ordering system described herein may operate with any front-endpharmacy solution and any back-end automated filling robot. The goal isto consolidate prescription or other tablet orders by combining theorders and generating an output. This is done by putting all the ordersinto a database and then gathering information about each order and thencombining this information with a photograph of each tablet that is alsostored in the database. The consolidated order information with theassociated written information and pictures of the tablets are combinedinto one booklet that is referred to as a patient information booklet.

Tablets as used herein may refer to any form of prescription ornon-prescription medication in the form of caplets, pills, capsules,powders, liquids, gels, or suppositories, including vitamins,supplements, herbal formulations, or combinations thereof, intended tobe ingested by or administered to a patient to improve the patient'shealth or well being.

The integrated label includes color pictures of the tablets.Additionally, the integrated label includes dosage periods (morning,noon, afternoon, evening) and information specific to the time frame(start date, no start date, week, month, 90-day period). The labelingmay be in large alphanumeric text for improved legibility for thevisually impaired.

Note, labeling may accommodate blind patient as shown and described inmore detail in U.S. Provisional Application No. 61/245,912, filed Sep.25, 2009, which is hereby incorporated by reference.

The integrated labeling is associated with the Patient InformationBooklet (PIB). The PIB includes standardized language that correspondsto each medication. The PIB combines information associated with aplurality of medications into a single document. The PIB is included inthe mail order package that is sent to the customer. The PIB isassociated with the multi-prescription container and the integratedlabel, and the three are combined before being placed into a shippingcontainer.

Referring to FIG. 1, there is shown an illustrative flowchart describingthe overall process used to go from prescription entry to ordershipment. At block 102, the enrollment form is received from a newpatient. Proceeding to block 104, the enrollment form may be accompaniedby the patient's written prescriptions, or the prescriptions may befaxed or otherwise delivered by the patient's physician(s). At block106, the patient information is entered into the front-end system. Inthis illustrative embodiment, the front-end system is PharmaServe. Oncethe patient has been entered into PharmaServe, additional informationincluding billing information and patient packaging preferences may beentered into Edge Prescription Processing Application (EPPA) at block108. The method then proceeds to block 110, where the prescription orderis verified.

Once the patient and prescription information have been entered into thefront-end system and into EPPA, each prescription is now associated witha particular patient's individual regimen. The prescriptions are groupedand treated as one order within the EPPA system. This function is notavailable in PharmaServe or in other known front-end systems. Theverified order is treated as a whole order from this point on in theprocess. Any additional prescriptions that the patient may require inthe future may be added to the patient's order when prescriptions arenext filled.

Moving on to block 112, the verified prescription order that isassociated with a particular patient and corresponds to specific datesfor administration is forwarded to production and filled. Theillustrative interface, EPPA, communicates with the back-end (filling)system, allowing the prescriptions to be grouped as an order duringfilling. In one illustrative embodiment, the back-end system is Pac-Med.

The filling process uses automated techniques. During the fillingprocess, the tablets that are associated with the prescription order maybe loaded into compliance containers that are configured for use withthe system and methods described herein, such as those described in U.S.patent application Ser. No. 11/923,321, filed Oct. 24, 2007, which ishereby incorporated by reference. Embodiments of compliance containersthat are configured to be used with the system and methods herein arealso described in more detail below.

The particular type of compliance container that is used during fillingis chosen according to patient packaging preferences.

Referring now to block 114 of FIG. 1, the method proceeds to printing ofthe integrated label and the patient information booklet. The integratedlabeling displays information relating to the patient. In someembodiments, a photograph of the patient may appear on the integratedlabeling. Integrated labeling also displays detailed information aboutthe tablets included in the prescription order. In some embodiments,color images of the tablets are included next to their names anddescriptions. Further, integrated labeling contains drug precautioninformation corresponding to the tablets in the order. Integratedlabeling may also include patient-specific or prescriptionorder-specific information, such as details about interactions betweentwo tablets in the order or interactions that the drug may have based oninformation that is specific to the patient, like age or the diseasethat is being treated. It is important to note that the steps of block112 and 114 may also occur in reverse order, or simultaneously, withoutdeviating from the system and methods described herein.

Also at block 114, the patient information booklet is printed. Thepatient information booklet is a consolidated booklet that displaysinformation related to each tablet in the prescription order. Thepatient information booklet may display all, or a portion of, theinformation that may be included on the drug information insert thataccompanies medications when they are dispensed in pill containers thathold just one type of tablet. The patient information booklet may alsoinclude more detailed information of the types described above inreference to integrated labeling, and it may contain other informationrelated to the patient and/or the prescription order that may be usefulto the patient or caregiver who uses the compliance packaging andpatient information booklet.

Moving on to block 116, the filled order is inspected. The inspectionprocess includes verifying that the tablets to be dispensed are properlyassociated with the particular patient and prescription order. Theinspection process also includes inspection of the filled packages toensure that the distribution of the tablets within the containers isconsistent with the patient's dosage regimen. Further, the integratedlabeling corresponding to a particular time period and specific datesfor administration is associated with the strip of pouches or cups thatcontain the associated tablets. The integrated labeling associated withthe order is also inspected and verified to be of legible print quality.Inspected strips are matched with the appropriate secondary containerand the corresponding integrated labeling.

Moving on to block 118, the strips are sealed within the appropriatesecondary container, and all secondary containers corresponding to acomplete order are placed into a shipping container. Moving on to block120, the shipping container with the prescription order within isforwarded to shipping for delivery to the patient.

Referring to FIG. 2, there is shown a plan view of an illustrative EPPAGraphical User Interface (GUI) main page 200. Starting on the left sideof the illustrative GUI 200, there is shown a series of tabs 202-214.Each tab is associated with a particular set of tasks or type ofinformation that needs to be interacted with. “People” tab 202 ishighlighted in this illustrative image. Other illustrative tabs that areassociated with steps in processing a patient prescription order include“Verification” tab 204, “Inspection” tab 206, “Shipping” tab 210, and“Production” tab 212. The illustrative “History” tab 208 allows a userof the GUI to pull up information related to the patient's history andthe history of any previous associated prescription orders. Theillustrative “Utility” tab 214 allows a user to manipulate EPPA settingsand the like.

Since the people tab 202 is highlighted, “People” folder 216 isdisplayed at the top of the display area 222 to the right of the tabs202-214 discussed above. The people folder 216 is shown in an expandedview, and subfolders physician 218, patient 220, guardian 224, payor226, user 228, or institution 230 may be selected. These subfoldersenable a user to obtain additional information about a person or entityof the type listed, or to enter such information. Below display area 222is a series of buttons that include new patient button 232, refillbutton 234, and new prescription button 236. Search box 238 also enablesa user to enter a search term in order to find or enter information.

Referring to FIG. 3, there is shown a plan view of an illustrative EPPAGUI for patient information entry. The illustrative patient informationentry GUI 300 is included under the highlighted people tab 202, asshown. The illustrative GUI 300 includes an area to enter or viewinformation about the patient's address and contact information 302.Information corresponding to a patient's name 312, street 314, city 316,state 318, zip 320, email 322, home phone 324, work phone 326, cellphone 328, or fax number 330 may be entered. If an individual other thanthe patient is the contact person for billing, the check box 310 may beunchecked and billing address and billing contact information 304 may beentered or viewed.

Additional patient information 306 may be entered, including thepatient's gender 332, date of birth 334, parent/guardian 336, spouse338, Social Security number 340, insurance provider(s) 342, insurancegroup ID 344, credit card information 346, cardholder name 348, cardexpiration date 350, password 352, and language choice 354. If theshipping address and contact information 308 is different than both thepatient information 302 and the billing contact information 304, thenthe choice “Different” may be clicked of the options 356, and theshipping information 308 may be entered.

Referring to FIG. 4, there is shown an illustrative flow chart depictingthe process 400 for entering a new patient into the system. First, atblock 402, the enrollment form is received from the patient. Theenrollment form is typically accompanied by the new patient's writtenprescriptions, or by an instruction for the patient's physician(s) to becontacted to obtain the prescription information. Next, at block 404,the patient's name is entered into the database. In this illustrativeembodiment, the patient name is entered into the illustrative front-endsystem, PharmaServe. The method then proceeds to decision diamond 406,where it is determined if the patient is already in the database. If thepatient is in the database, the patient is not a new patient and themethod proceeds to EPPA (Edge Prescription Processing Application) entryat block 416. If the patient is not in the database at decision diamond406, the method proceeds to block 408, where the rest of the patientinformation is entered, possibly including patient information of thetypes described above for FIG. 3 EPPA patient entry. The method thenproceeds to block 410, where any patient allergies are entered into thesystem. Proceeding to block 412, any patient medical conditions areentered, and moving on to block 414, the patient's detailed carriercoverage information is entered. The method then proceeds to block 416,where EPPA entry begins, and on to decision diamond 418, where it isdetermined if the patient is in the EPPA database list. If not, themethod returns to block 404. If so, the method moves on to block 420,where patient billing information including credit card, driver licensenumber and state is entered into a GUI similar to the one shown in FIG.3. Patient notes that may describe anything related to the patientand/or the disease for which the patient is being treated and/or theprescription(s) that the patient is taking may also be entered. Movingto block 422, any patient packaging preferences are entered. Finally,the method proceeds to block 424, and the new prescription entry processbegins (shown in more detail in FIG. 6).

Referring now to FIG. 5, there is shown an illustrative GUI for enteringadditional prescription information. This information includes dataabout the insurance the covers the prescription, coverage (Cvg)information 502, prescriber information 504, refills authorized (RflsAuth) 510, instructions (Inst) 512, frequency (Freq Ovrd) 514, thenumber of days supply 516, the origin of the tablets to be filled 518,the date the prescription was written 520, the date the prescription isbeing dispensed 522, the prescription expiration date 524, thepharmacist who is supervising the fill 526 and the hours ofadministration (HOA) information 528.

Referring now to FIG. 6, there is shown an illustrative flow chartdepicting the process 600 for entering a new prescription order into thesystem. At block 602 of the method 600, patient selection criteria areentered into PharmaServe. Patient selection criteria may include patientlast name, patient phone number, or other identifying information. Themethod then proceeds to decision diamond 604, where it is determined ifthe patient name is in the list of patients. If the name is not in thelist of patients, the method proceeds to block 622, where method 400(described in FIG. 4) is performed. If the patient name is found in thelist of patients, the method proceeds to block 606, where the patientname is selected from the list. At block 608, the name of a newprescription associated with the patient is entered.

The method then proceeds to block 610, where additional informationrelating to the prescription is entered. This information is enteredinto an illustrative GUI similar to the one presented in FIG. 5. Thisinformation may include coverage (Cvg) information 502, prescriberinformation 504, refills authorized (Rfls Auth) 510, instructions (Inst)512, frequency 514, the number of days supply (Days (supply)) 516, theorigin of the tablets to be filled 518, the date the prescription waswritten 520, the date the prescription is being dispensed 522, theprescription expiration date 524, and the pharmacist who is supervisingthe fill 526.

Referring back to FIG. 6, the method proceeds to block 612, where theHOA code 528 (shown in FIG. 5) corresponding to the time(s) andfrequency that the medication should be taken is entered. The HOA codeenables an individual prescription to be integrated into anindividualized regimen and associated with the proper medicamentcontainer for eventual administration.

The method then proceeds to decision diamond 614. If the patient hasadditional new prescriptions to be added, the method returns to block606. If all new prescriptions have been added to the system, the methodproceeds to 616, where the illustrative “Bill Now” command is entered,which ends the data entry process. The method then proceeds to block618, where the handwritten prescriptions corresponding to eachprescription to be dispensed are scanned into the system. Finally, themethod proceeds to block 620, where the order is complete.

Referring now to FIG. 7, an illustrative process 700 for entering arefill prescription is shown. At decision diamond 702, the methodselects whether the prescription is known. If not, the method proceedsto block 716, where at least one patient selection criterion is entered,and on to block 718, where the patient name is selected from a list. Themethod then proceeds to block 720, where the prescription to be refilledis selected from a list associated with the patient.

Alternatively, if the prescription number is known at decision diamond702, the method proceeds to block 704, where the prescription number isentered. In either case, the method proceeds from either block 704 or720 to block 706, where the option “Refill” is selected. The method thenproceeds to block 708, where the HOA code associated with the particularpatient and particular prescription is entered.

The method then proceeds to decision diamond 710, where it is determinedif the patient has additional prescriptions to be refilled. If thepatient has additional prescriptions to be refilled, the method proceedsto block 720, where the next Prescription to be refilled is selected.The method then moves on to block 706, where the ‘Refill’ option isselected; next, the method proceeds to block 708, where the HOA codeassociated with the particular patient and particular prescription isentered. The method then returns to block 710, and it is againdetermined if there are additional prescription to refill.

When there are no prescriptions left to refill, the method proceeds fromdecision diamond 710 to block 712, where the label and billinginformation associated with the prescription order is verified. Themethod then proceeds to block 714 where the order is complete.

Referring now to FIG. 8, there is shown an illustrative prescriptiondisplay comparison EPPA GUI 800. The illustrative GUI 800 is configuredto display an image of the scanned handwritten prescription forcomparison and/or data entry. Information about a specific prescriptionin a prescription order may be entered into this illustrative GUI 800.The scanned prescription 802 appears in the display window at the rightof the GUI 800. Information including patient name 804, prescriptionnumber 806, the name of the drug written on the prescription 810, thename of the dispensed drug 812, the number of days supply 814, thequantity of tablets 816 that corresponds to the number of days supply,the HOA code 818, number of remaining refills 820, dosage quantity 822,the quantity of tablets 824 that corresponds to the dosage quantity, thesig code(s) 826, the prescriber name 828, route of administration 830,the prescription expiration date 832, the date written 834, and the dateentered 836 may be viewed or entered into GUI 800. Additionally, dosageinstructions 838 and notes 840 may be viewed or entered into GUI 800. Insome embodiments, a user is able to make notations on the electronicimage of the prescription as a removable layer such that the originalprescription image can be viewed in the GUI with or without thenotations.

With respect to FIG. 9A, an overview of the prescription orderverification process is shown. The verification process authenticatesthe accuracy of each prescription input. First, at block 902, apatient's history is reviewed. The patient's history is compared to theplurality of prescription inputs to ensure therapeutic appropriateness.

As used herein, therapeutic appropriateness refers generally to thesuitability of an integrated prescription order (or, the totality ofprescription inputs) for a particular patient. Therapeuticappropriateness is determined by a number of factors. For instance, oneimportant factor is whether a patient has a history of overuse or abuseof one or more drugs in the integrated order. Additionally, a patient'shistory of compliance (e.g., underuse or irregular use) as well as areported effectiveness/ineffectiveness may be considered. An integratedorder may be further evaluated to ensure that no medications in theorder contain any substance known to cause an allergic reaction in thepatient. A patient's medical diagnosis (e.g., recovering, terminallyill, advanced, intermediate, and early stages) may also aid indetermining the therapeutic appropriateness of an integrated order.Therapeutic appropriateness may also depend on the likelihood ofinteraction—i.e., between several medications in an integrated orderand/or between medications in the order and medications a patient istaking, or has recently taken, not associated with the order. Finally,the determination may include an evaluation of an integrated order toensure that there are no therapeutic duplications or contraindications.

After it has been determined that an integrated prescription order istherapeutically appropriate, at block 904 it is determined whether thereare any notes associated with a particular patient. These notes maydescribe changes to a patient regimen as well as any other pertinentinformation. If notes exist, the method proceeds to block 906, where thenotes are processed or read and any necessary action referred to in thenotes is taken. Thereafter, the process continues to block 908. If, onthe other hand, there are no patient notes, the process simply advancesto block 908. Beginning with block 908, the original handwrittenprescription orders, or scanned images thereof, are compared to theirassociated prescription inputs to ensure that the prescription inputsare correct. More particularly, for each prescription input, thepatient's name and date of birth are verified (block 910), the date thatthe prescription was written is verified (block 912), the drug strength,drug quantity, number of refills, and presence of a physician'ssignature are verified (block 914), the prescriber information isverified (block 916), the dispense as written (DAW) designation isverified (block 918), and, finally, the drug, the dosage, and the dosagefrequency are verified (block 920).

If a prescription input can be verified at all of blocks 910-920, theprescription input is verified and approved by a pharmacist at block932, a label is affixed to the back of the prescription order at 934, averification label is initialed by a pharmacist at 936, and theprescription input is released to be filled by a filling machine at 938.

If a prescription input cannot be verified at one or more of blocks910-920, an attempt may be made to correct the invalid prescriptioninput at diamond 922. Corrections are made by re-entering all of theinvalid portion of the prescription input. If possible, the invalidprescription input is corrected at block 930, whereafter theprescription input is verified and approved by a pharmacist at 932, alabel is affixed to the back of the prescription order at step 934, averification label is initialed by the verifying pharmacist at block936, and the approved prescription input is released to be filled by afilling machine at block 938.

If, however, a prescription input cannot be corrected as specifiedabove, clarification by the patient or prescriber may be required. Ifclarification is required, the method proceeds to block 924, where allcorrect prescription inputs (i.e., those that do not requireclarification) are verified by a qualified pharmacist. Thereafter, alabel is affixed to the back of each associated prescription order andinitialed by a pharmacist. Prescriptions may be clarified by contactinga patient or physician via email, facsimile, telephone, or any othersuch means; and, the inquiry may be made for additional or correctedinformation. Once the order is clarified, the method proceeds to block936, where the verification label for each prescription is initialed bya pharmacist. Finally, the clarified (and verified) order is releasedfor filling at block 938.

Referring to FIGS. 9B through 9E, an embodiment of a verification GUI isdisplayed. The verification GUI comprises a software module and isconfigured, in broad terms, to display one or more prescription inputsfor review by a pharmacist or, potentially, by a software moduleconfigured to verify and approve prescription inputs. As described abovewith reference to FIG. 9A, a pharmacist may utilize the verification GUIas a means for comparing each prescription input to a hardcopy orscanned image of its associated prescription order.

To that end, referring now to FIG. 9B, the verification GUI firstcomprises a patient/order selection interface 940. The patient/orderselection interface 940 comprises a plurality of tabs for performingvarious operations. More particularly, the interface 940 comprises alogin tab 942, an orders tab 944, a verification tab 946, an inspectiontab 948, a patient tab 950, and a barcodes tab 952. However, dependingupon a user's (e.g., a pharmacist's) capability profile fewer than allof the tabs may be displayed on successful login. After the orders tab944 is invoked, the software groups all outstanding prescriptions anddisplays a list 954 of all patients with outstanding orders. Referringto FIG. 9C, selecting a patient from the list 954 of patients withoutstanding orders populates the right hand side of the patient/orderselection interface 940 with a list of all of the unverified andoutstanding prescription orders 956 for the selected patient. Doubleclicking a patient name or selecting the Verify button 958 at the bottomright hand corner of the interface 940 populates and invokes theverification tab 946.

Under the verification tab 946 the software displays all of theunverified prescription inputs. Here, there are two example prescriptioninputs, 960 and 962. These are the prescription inputs that requireverification and approval, as described above with reference to FIG. 9.More particularly, the verification GUI displays the informationassociated with each prescription input, whereby a pharmacist maycompare the information displayed by the GUI to the information on,either, a hardcopy prescription order corresponding to the prescriptioninput she is viewing, or a scanned image of the prescription ordercorresponding to the prescription input she is viewing. A checkbox 970labeled “Show original prescription” permits the user to toggle betweena first view (FIG. 9D) and a second view (FIG. 9E). Referring to FIG.9E, the second view juxtaposes each prescription input 960 and 962 witha scanned image of the associated prescription order 972 and 974,respectively.

After verifying all the information in a particular prescription input,the pharmacist may approve the prescription input by checking a box, 964and 966, labeled “Approved” associated with the particular prescriptioninput, 960 and 962 respectively. Alternatively, a pharmacist maydetermine that a prescription input is inconsistent with its associatedprescription order, in which case the pharmacist may choose to leave theApproved box associated with the invalid prescription input unchecked.

The pharmacist may indicate that verification has been performed byentering an input into the GUI, for example, by activating a“Verification Complete” button 968 after she has reviewed all of theprescription inputs. Other means for entering an input using a GUI, suchas ticking a checkbox, entering a note in a data field, or entering asignature on a touchscreen interface, may be used in the GUI to allowthe pharmacist to indicate that a verification has been performed.Selecting the Verification Complete button 968 causes each of theprescription inputs associated with a patient and displayed in theVerification tab 946 to be grouped as an integrated order and assigned aunique ID number. Further, the approved prescription inputs are nolonger shown under the Verification tab 946, nor is the selected patientdisplayed under the Orders tab 944, provided of course that thepharmacist approved all outstanding prescription inputs associated withthe patient.

The patient compliant medicament dispensing containers described hereinare available in many different styles, allowing patients to makedecisions about the type of medicament packaging that will best suittheir needs. Patient-selectable packaging for multiple medicationcompliance regimens allows a patient to choose a medicament containersystem on the basis of several factors, including ease of opening,childproofing features, number of tablets to be consumed daily, anddesired dosage grouping (7-day or 30-day).

Many younger individuals take only a few prescription medications. Mostof these patients are able to easily open any of the many types ofpackaging available. A primary concern for this type of patient may beportability and sturdy construction of the packaging. The complianceaspect may be very simple—the package may just make the medications morereadily portable than needing to take several bottles of pills aroundAND having to remember whether one took them that day or not. Further,this type of patient may travel often, and may desire that medicationsare dispensed in smaller dosage groupings, such as a 7-day grouping, toavoid having to carry around medications for an entire month when onlytravelling for a few days.

Patients with small children may find it is important that the packagingis child-proof. The compliance aspect will also help ensure parents thattheir medications are safe from tiny hands, since missing medicationwould be easy to detect.

On the other end of the spectrum, a patient who possesses limited manualdexterity may need a container system that is easy to open or mayrequire assistance to take medications. Patients who consume severaltablets at frequent intervals throughout the day or having manyprescriptions to manage may benefit from compliance packaging indicatingwhen tablets have been consumed. For a patient living in an assistedliving facility or utilizing a caregiver, a compliance container systemfacilitating ease of distinguishing one patient's medications fromanother's may be preferred.

FIG. 10 shows an illustrative patient interface, including packageselection options. The illustrative GUI 1000 embodiment is configured toreceive a prescription order, a direct order, or any such order relatedto medications, vitamins, supplements, herbs, oils, or any suchsubstance that is associated with a particular patient. The illustrativeGUI 1000 includes fields for the name of the patient 1002 and thepatient's address 1004. Additional information about the individualplacing the order may also be requested, such as the individual'stelephone number 1006 and e-mail address 1008. Information about thepatient such as date of birth 1010, height 1012, weight 1014, and sex1016 can also provided to the illustrative GUI 100. The user can inputinformation about the patient's medical conditions 1020, informationabout the patient's doctor 1022, allergies 1024, and current medications1026 being taken by the patient.

Furthermore, the user may select specific ordering options such as thetype of packaging to be used for the medication. For example, aplurality of single packages 1028 may be requested for multiplemedications. Also, a multiple prescription package 1030 or“multi-script” package may be requested. The multiple prescriptionpackage may include a variety of user selectable options such as type ofpackage, size of package, and child resistant packaging. The type ofpackage may include a sleeved package or a spiral package as describedbelow. Alternatively, the packaging may employ other packagingtechniques such as grid packaging or the use of plastic bags.

Data fields are also provided for identifying the requested medications1032 that include a description of the product 1034, the dosage 1036,the quantity 1038, and the type of drug 1040. The type of drug 1040 mayinclude information about whether the drug is generic or name brand. Ifthe product is available, the on-line ordering system may then provide aprice 1042 for the product. A sub-total 1044 is then provided, andshipping costs 1046 are identified. A final order total 1048 is thenpresented to the user. The patient may then provide a card 1050 such asa credit card, a debit card or any other such information for conductingan on-line transaction. The name, the card number, the type of card andthe expiration date of the card are requested in the illustrativeembodiment.

Referring to FIG. 11 there is shown a 30-day tablet regimen for thepatient medication management system that uses the seven-day box. Apatient medication management system 1100 provides a compliancepackaging solution. The patient medication management system 1100described herein provides a compliance package because, firstly, anaction is required by the patient or caregiver that requires identifyingthe appropriate dosage period, e.g. morning, and selecting theappropriate pouch. Secondly, the patient opens the appropriate pouch andconsumes the medication. Thirdly, the patient or caregiver records theconsumption of the medication by removing or pressing the circular cuts.

The patient medication management system 1100 comprises a plurality ofsealed pouches that are grouped into four separate strips 1102, 1104,1106 and 1108. The first strip 1102 is a seven day strip that covers theillustrative dates of Sep. 22, 2007 through Sep. 28, 2007 and theillustrative dosing period is the “morning.” In the illustrativeembodiment, the dosage period is selected from the group of dosageperiod intervals consisting of a morning dosage interval, a noon dosageinterval, an evening dosage interval, or a bedtime dosage interval.

The first strip 1102 is placed into the illustrative folded box 1110that has the tablets corresponding to the first week of the 30-dayregimen. The second strip 1104 is a seven day strip that covers theillustrative dates of Sep. 29, 2007 through Oct. 5, 2007. The dosingperiod remains the same, i.e. morning. The second strip 1104 isassociated with folded box 1112 that houses the tablets corresponding tothe second week of the 30-day regimen. The third strip 1106 is a sevenday strip that covers the illustrative dates of Oct. 6, 2007 throughOct. 12, 2007 and, again, the dosing period is the morning. The thirdstrip 1106 is associated with folded box 1114 that corresponds to thethird week of the 30-day regimen.

The fourth strip 1108 includes a seven day grouping of pouches 1116 thatcovers the illustrative dates of Oct. 13, 2007 through Oct. 19, 2007;the dosing period remains the same, i.e. morning. Additionally, an emptypouch 1118 is included with the fourth strip 1108 that provides areminder to place another order and an illustrative 800 number to assistin placing the refill order. Furthermore, a two day grouping of pouches1120 covers the illustrative dates of Oct. 20, 2007 through Oct. 21,2007. The fourth strip 1108 is associated with folded box 322 thathouses the tablets corresponding to the fourth week of the 30-dayregimen. Thus, the fourth strip 1108 includes nine pouches that completethe 30-day regimen.

Each of the strips 1102, 1104, 1106 and 1108 are placed in thecorresponding folded box 1110, 1112, 1114 and 1122, respectively. Eachfolded box or “primary container” is configured to receive at leastseven pouches. Note, the terms folded box, assembled box, and “primarycontainer” are used interchangeably through out this patent. Thus, eachprimary container is configured to receive at least seven pouches thatcorrespond to the particular dosage period and the illustrative primarycontainer is labeled with the dosage period corresponding to themedications. Additionally, each primary container may be labeled withthe patient name and dosage period as described above.

Each folded box or primary container comprises a plurality of dailyindicators corresponding to a seven-day period that are disposed on theprimary container. The daily indicators provide a means for recordingthat the medications in the pouch have been taken. An illustrativeembodiment of the daily indicators has been provided above thatdescribes a plurality of circular cuts 1158 on the folded box. Each ofthe daily indicators is configured to indicate that the medications inthe pouch have been taken, thereby providing a means for compliancepackaging.

In the illustrative 30-day regimen, the sealed pouches associated withstrips 1102, 1104, 1106 and 1108 include sealed pouches with a pluralityof different tablets that correspond to different medications and/orvitamins. The different medications are associated with at least oneprescription and each tablet includes an appropriate dosage consistentwith the prescription. Each of the sealed pouches is labeled to show themedications in the pouch and labeled with a particular dosage periodthat includes at least one daily interval for consuming the medicationsin the pouch.

Referring to FIG. 12 there is shown a label area on a pre-assembledblank 1290. The information on label 1292 is located on the front faceof the blank 190 and includes information that is associated with aparticular patient. The label 1292 may be affixed separately as aseparate label, printed on the blank 1210 in the label area, or anycombination thereof. The label area includes the top wall 1212, and topside flaps 1216 a and 1216 b.

Referring to FIGS. 13A-13B, there is shown an isometric view of the30-day tablet dispensing container 1300. In general, the illustrative30-day tablet dispensing container is a foldable box that includes a topwall, a front side wall, a right-side wall, a back side wall, aleft-side wall and a bottom wall. The top wall has one end fixedlycouple to the foldable box and an opposite end that provides a foldablelid. The front side wall has a removable lid that is bordered by aplurality of perforations. The right-side wall abuts the front side walland the top wall. The back side wall abuts the right-side wall and thetop wall. The left-side wall abuts the top wall and is between the backside wall and the front side wall. The bottom wall abuts the frontside-wall, the right-side wall, the back side, and the left-side wall.The container is formed to receive a plurality of pouches as describedherein.

By way of example and not of limitation, the illustrative cardboard usedto construct container 1300 includes an outer smooth layer of paper anda thick interior layer. The outer smooth layer may receive printed textor images using an illustrative laser printer, ink jet printer, or othersuch printing means. Additionally, the outer layer may also beconfigured to receive a label that is affixed thereto.

In the illustrative embodiment, a perforated, removable lid 1304 makesup a large portion of the front side wall 1306 and top wall 1302 of theillustrative container 1300. The lid can be partially or completelyremoved in order to access the medicament pouches within the container1300. In one embodiment the lid 1304 may only occupy one wall such asthe front side wall. In the illustrative embodiment, the lid occupiesthe front side wall 1306 and extends to the top wall 1302.

The illustrative top wall 1302 has one end fixedly coupled to thefoldable box and an opposite end that provides a foldable lid. Asecondary label (not shown in exploded view) is configured to seal thefoldable lid on the top wall. In the illustrative embodiment, thesecondary label has a bar code and includes the time interval when thetablets should be administered or taken. In the illustrative embodiment,the secondary label 1375 visible on top wall 1302 of the container 1300indicates the time period 1370, the filling date 1374, and theprescription start date 1376 listed above the perforations of lid 1304.

Referring now to FIGS. 14A-14B, a top view and a bottom view of aplurality of illustrative sealed multiple prescription containers 1420is shown. Both views reflect that one of the containers 1421 comprises atapered body container 1422 with a cavity for holding a plurality oftablets. The tapered body container 1422 allows a plurality ofindividual containers to be stacked for storage. Each container 1420 hasa flanged top surface 1424 configured to be sealed with a lid 1426. Incertain embodiments, the tablet assembly may require individualcontainers that vary in depth depending on the amount of tablets neededto be dispensed at a specific time. While the depth of the individualcontainers may vary, the flanged top surface and collar remain constantfor processing of different sized individual containers and forcommonality with the assembly sleeve.

In one embodiment, the multiple prescription container assemblycomprises a plurality of individual containers. In one illustrativeembodiment, container 1421 is coupled to container 1428 with lid 1426.The lid 1426 seals one or more containers. The sequential connectionenables a linear configuration for the individual containers.

However, it should be noted that the quantity of containers in amultiple prescription assembly may vary as well as the interconnectionconfiguration of the containers, e.g. a circular, an elliptical,polyhedral, etc.

In another embodiment, the plurality of multiple prescription containersare made from a single piece of moldable material having a plurality ofindentations wherein each indentation is configured to form onecontainer 1421 in the set of containers 1434. At least one of thecontainers is configured to receive a first tablet associated with afirst medication, and a second tablet associated with a secondmedication that is different from the first medication. The set ofcontainers 1434 are connected to one another by frangible connections1436 or perforations positioned within the flanged edge 1424 that areproximate to the adjacent container. The frangible connection 1436,which is between containers, allows the containers to “break-away” fromthe set of containers 1434 in a sequential manner. Once the lids areattached and/or sealed to the top flanged surface 1424, this sequentialconnection enables a linear configuration as described above.

Each container may also comprise a collar 1438 below the flanged edge1424 that allows the containers to be stored in a stackableconfiguration. Stacking of the containers can also be performed with thecollar 1438. Each container may also comprise a bottom surface 1440 withat least one ridge 1442. The ridge is useful in minimizingtablet-to-tablet collisions and avoiding medication sloughing off of atablet due to collisions with other tablets. By limiting excessivemovement of the tablets in each of the containers, the ridge or ridgeson the bottom of the container(s) help preserve the integrity of thetablets within. The ridge may protrude outward from the bottom surfaceof the containers, or in other embodiments, may be formed by anindentation of the bottom surface. The ridge(s) may be configured as asquare, rectangle, circle, and a plurality of parallel lines as well asother geometric shapes.

The illustrative set of containers 1434 comprises seven adjacentcontainers configured for sequential dispensing of the contents of eachcontainer. Sequential dispensing refers to individual containers being“dispensed one at a time,” which is different from being “cherry picked”from a grid of individual containers. The number of containers in a setof integrated containers may vary due to the prescription prescribed forthe user. While the illustrative embodiment describes seven containers,a set of containers may comprise at least two containers to about 20containers, and more preferably about 10 to about 14 containers. It isexpected that most of the containers will be of similar size for ease offilling the containers, but in certain embodiments varying containersizes may be needed. The set of containers 1434 may be opaque but inpreferred embodiments, the moldable material is sufficiently transparentfor the user to see the contents of the containers.

The illustrative lid 1426 of container 1421 comprises a printing surfacewhere unique prescription-specific information is displayed for eachcontainer. The information displayed on the printing surface mayinclude, but is not limited to, the patient's name, the date and the dayof the week the contained mixed dosage medications (tablets) are to betaken, as well as the time of day that the tablets are to be taken. Themarkings on the containers inform the patient and/or caregiver the timein which the contents of the container are to be taken in the propersequence. In general, the lid stock comes from a roll and theappropriate amount of lidstock is released from the roll to accommodatethe designated number of containers to be sealed. For a thermoformedcontainer, using polypropylene for the material for the lid stock, anunsealed area of lid film is generally used to help in the peeling ofthe lid. The breakaway tab 1432 on the illustrative container 1421 givesthe user something to hold onto and is a useful feature to a containerthat is manufactured by injection molding with plastics likepolyethylene or styrene.

Referring to FIG. 15 there is shown an exploded isometric view of themultiple prescription container assembly 1550 prior to being assembled.The exploded view also shows a top tab 1554 on the top surface 1556 ofthe sleeve which holds the end container 1558 by catching therectangular void made by one of the indentations 1560. When the userpushes down the sleeve tabs 1562, the set of sealed containers arereleased and the top tab 1554 is disengaged from the containers. The endcontainer 1558 can be slid out of the dispensing sleeve 1552 if thereare no other child protective features, and the top tab latches on tothe next indentation (not shown). The user then can break the frangibleconnection 1564 and remove the container. This two-step process ofholding tabs 1562 and pulling on the end of the sealed containers is a“child safety” feature. It shall be appreciated by those skilled in theart that certain embodiments can be made to conform to a moresenior-friendly solution that is described in further detail below.

Additionally, there is shown a notch 1563 that is configured to be fitinto an illustrative cavity that is a square-shaped perimeter 1565 andreceives a notch similar to notch 1563. The notch 1563 permits twodispensing sleeves to “snap” together. The square shaped perimeter 1565is located on the edge of the dispensing sleeve 1552 and has a squarecut and a lip. Printed material 366 may be attached to the top surface1556 of the dispensing sleeve 1552. Additional information about theprescription or other patient data can also be placed on the dispensingsleeve 1552. The dispensing sleeve 1552 may also comprise a surface forprintable indicia, and the printable indicia may include patient data aswell as prescription information.

Referring to FIG. 16 there is shown an isometric view of the multipleprescription container assembly 1650. The end container 1635 can be slidout of the dispensing sleeve 1668 if there are no other child protectivefeatures, and the top tab latches on to the next indentation (notshown). The user then can break the frangible connection and remove thecontainer. This two-step process of holding tabs 1680 a and 1680 b andpulling on the end of the sealed containers is a “child safety” feature.It shall be appreciated by those skilled in the art that certainembodiments can be made to conform to a more senior-friendly solutionthat is described in further detail below.

FIG. 17 is an illustrative top view of multiple sleeves coupled to oneanother and depicting the sequential dispensing of a container. In thisillustrative example, the multiple prescription container assembly isfor patients that must take multiple medications more than once a day.The multiple prescription container assembly 1720 comprises a pluralityof thermoformed (or molded) sets of sealed container 1722 a, 1722 b, and1722 c that are heat sealed with a laminated lid 1724 a, 1724 b, and1724 c, respectively. Each container within the set of containers 1722a, 1722 b, and 1722 c contains the required medications that have beenprescribed for a particular time. The containers are separated byperforations as described above. In the illustrative embodiment, eachcontainer contains printed markings 1726 that identify the medicationscontained therein, and may also indicate the patient's name, and, mostimportantly for the purposes of this embodiment, the day and the time ofday that the medications are to be taken.

In the illustrative embodiment of FIG. 17, each container is dedicatedsolely to a particular time of day. In the illustrative example, the setof containers 1722 a are taken in the morning, the set of containers1722 b are taken at approximately noon, and the set of containers 1722 care taken in the evening. Thus, it is possible to have a plurality ofcontainers for each day of the week so that each container has theproper dosage that is to be taken at a particular time of day. In thisillustrative embodiment, the patient is supplied with a complete set ofcontainers for a particular week for a specific time of day.

Each individual container within each set of containers is to be takenat the correct, prescheduled time each day as marked on each container.The multiple prescription container assembly 1720 may be provided to thepatient or caregiver as three separate sets of containers enclosed inthree separate dispensing sleeves. The patient or caregiver caninterlock the three separate dispensing sleeves 1728 a, 1728 b, and 1728c.

FIG. 18A, FIG. 18B and FIG. 19 show one embodiment of a medicamentcontainer or cup 1840 for holding medication in the form of tablets,caplets, pills, capsules, powders, liquids, gels, suppositories or otherform of medication. The medication within containers 1840 may beprescription medication, vitamins, supplements, herbal formulations, orcombinations thereof, intended to be ingested by or administered to apatient to improve the patient's health or well being. The medicamentcontainer 1840 comprises a tapered body 1860 with a cavity 1870 forholding a plurality of pills or other medication. The container 1840includes a flanged top surface or edge 1850 configured to be sealed witha lid (not shown). Container 1840 may also include a frangible orremovable top or lid (not shown) adjacent to flange 1850. Breaking orremoving the top allows a user to access the medication therein. The topmay be transparent to allow a user to see the contents of container1840.

Generally, the flanged top edge 1850 of container 1840 comprises a firstside 1880 and second 1890 side which are configured such that flange1850 interacts with the spiral grooves or tracks of a packaging systemsuch that container 1840 can slide or otherwise move along the tracks.The flange top edge 1850 further comprises a third side 1900 and fourthside 1910. When containers 1840 are arranged in a chain, side 1900 ofone container 1840 is positioned adjacent side 1910 of an adjacentcontainer (except for the first container 1840 in the chain). Top edgesides 1900 and 1910 of adjacent containers 1840 can be connected to oneanother by a frangible interface 1855. The containers 1840 can then bedetached from one another by breaking the connector 1855.

Each container 1840 includes protrusions or ribs 1920A, 1920B on theexterior of tapered body 1860 of the container 1840. Ribs 1920A and1920B each support a tab section 1930A and 1930B respectively, with tabs1930A, 1930B located adjacent top flange 1850. The tabs 1930A and 1930Bare configured to interact with sprocket teeth on compliance wheel 1960to allow the container 1840 to be moved as teeth 1960 apply force totabs 1930A, 1930B when wheel 1970 is rotated. The ribs 1920A and 1920Band tabs 1930A and 1930B may in many embodiments be configured to aid inchildproofing the packaging system, as described further below.Counter-clockwise rotation of wheel 1960 results in teeth 1970 applyingforce to tab 1920A to move container 1840 in one direction, whileclockwise rotation of wheel 1950 results in teeth 1970 applying force totab 1920AB to move container 1840 in the opposite direction.

The tapered body 1860 of each container 1840 further comprises anarcuate or concave portion 1940 positioned between the ribs 1920A and1920B. Top flange 1850 includes an arcuate or concave portion adjacentto the concave portion 1940 of container body 1860. The configuration ofthe concave portions 1940 and 1950 of the container 1840 allows theteeth 1970 of compliance wheel 1960 to engage the tab portions 1930A,1930B of the container 1840 without interference from the tapered body1860 of the container 1840.

Referring now to FIG. 20, there is shown still another embodiment of amedication packaging system 2000, wherein like reference numbers areused to denote like parts. The spiral medication packaging systems maybe modular and attachable to each other to form extensible or scalablemedication packaging systems in a similar manner as described above. Theapparatus 2000 includes a child proofing barrier element 2010 movablymounted in wall 2020 adjacent to opening 2030. Barrier 2010 is movablebetween an open position (as shown in FIG. 20) that allows container1840 to pass through opening 2030, and a closed position (not shown)wherein container 1840 is blocked by barrier 2010 such that container1840 cannot exit or be removed through opening 2030. A spring or biaselement (not shown) may be operatively coupled to barrier 2010 such thatbarrier 2010 remains in the closed position unless a user appliessufficient force to barrier 2010 to overcome the bias and move barrier2010 to the open position.

In the embodiment of FIG. 20, barrier 2010 includes an arcuate or curvedlip 2040 that is configured to cover and block corners 2050 of container1840 when barrier 2010 is in the closed position, and which allowscorners to pass over or clear lip 2040 when barrier is in the openposition as shown in FIG. 20.

To operate the apparatus 2000, a user simultaneously pushes on ordepresses barrier 2010 to the open position while advancing compliancewheel 2060 to move container 1840 through opening 2030. When thecontainer 1840 has passed through opening 2030, the container 1840 isdetached and removed from the apparatus 2000, and the barrier 2010 isreleased to return to the closed position. The next container 1840 isthen blocked by barrier 2010 from exiting the apparatus 2000 until thechild proofing barrier 2010 is again depressed or moved to the openposition. Simultaneous manipulation of the compliance wheel 2060 andbarrier 2010 are sufficiently difficult that small children are unableto access the medication within apparatus 2000.

Referring now to FIG. 21 there is shown an isometric view of the spiralmedication packaging system 2000 in accordance with the invention,wherein like reference numbers denote like parts. The apparatus 2100includes transparent outer facings or housing elements. Housing element2110 is visible on the apparatus 2100 in FIG. 21.

Operation of the child proof barrier 2010 will be more fully understoodby making reference to FIGS. 22 and 23, wherein like reference numbersdenote like parts. FIGS. 22 and 23 show a portion of a modular system2200 wherein the child proof barrier 2010 in packaging system 2200B isshown in the closed position, and wherein the barrier 2010 is shown inthe open position in adjacent packaging system 2200A. In the closedposition as shown in system 2200B, arcuate lip 2040 of barrier 2010blocks the lower corners of container 1840 to prevent container 1840from being removed through opening 1830. In the open position shown insystem 2200A, the lower corners 2050 of container 1840 are clear of lip2040 and container 1840 may be advanced through opening 2030 byoperation of compliance wheel 2110. The arcuate shape of lip 2040accommodates a user's finger and facilitates manipulation of barrier2010 and container 1840.

During the filling process, integrated labeling is produced and affixedto the medicament containers. Integrated labeling is a unique feature ofthe system and methods described herein. Integrated labeling includesinformation about the patient, the medications the patient is taking,and other illustrative information. Integrated labeling may includeextensive labeling on the primary medicament containers (such as thepouches or medicament cups that directly hold the medication. Oneillustrative example of this labeling is shown in FIGS. 24A-24C.Integrated labeling may also include extensive labeling on the secondarycontainer that may hold a plurality of primary containers, as shown inFIGS. 25A-25G. Integrated labeling may also include a PatientInformation booklet. Illustrative integrated labeling is described inmore detail below.

Referring to FIG. 24A there is shown a group of seven separable pouches,wherein each pouch comprises a plurality of different tablets. Theseparable sealed pouches have been grouped into a collection of sevenpouches 2490 that correspond to a seven day supply of medications. Aplurality of sealed pouches that is grouped is also referred to as a“strip,” and the terms “strip,” “group of pouches,” and “strip ofpouches” is used herein interchangeably.

Referring to FIG. 24B there is shown an exploded view of theillustrative front side of one of the sealed center cut pouches 2492that is included in the strip of pouches 2490. The exploded view showsthat a variety of data fields that are printed on the front of eachpouch. In general, the data fields provide information corresponding toeach tablet within the pouch. The data fields includes: the name of thepatient 2494 a; the date the tablets should be consumed 2494 b; the timeof day the tablets should be taken 2494 c; the name of the prescribedmedication 2494 d; the name of the corresponding generic 2494 e; thedosage 2494 f; and the prescription number 2494 g. Additionally, anexpiration date 2494 h is included that identifies the medicationsshould not be taken after the expiration date.

Referring to FIG. 24C there is shown an exploded view of theillustrative back side of the pouch 2492 in FIG. 24B. The data fieldsinclude: the name of patient 2496 a; a bar code 2496 b; the address ofthe facility that filled the pouches with tablets 2496 c; and thetelephone number 2496 d for additional information. The illustrative barcode associates the tablets in the foldable box with a particularpatient. The illustrative seven-day strip 2490 is then placed in anillustrative seven-day container. These illustrative containers are thenplaced in a secondary container.

Referring to FIGS. 25A-25G there is shown an illustrative label of thetype that would be affixed to a secondary container. The label 2500 maybe affixed separately or the label may be printed directly on thecardboard or may be printed as a label that is separately affixed.

The illustrative label 2500 comprises a plurality of printed text thatmay include: the patient's name 2540, the interval during which themedications are taken, e.g. morning, a picture of the patient 2542,patient number 2544, order number 2546, a list of precautions 2548, alisting of the medications 2550, a listing of the time interval fortaking the medications 2552, a prescription number 2554, quantity oftablets 2556 per prescription, quantity of refills 2558, length ofprescription 2560, the prescribing physician 2562, the manufacturer ofthe tablets 2564, and the lot number 2566 corresponding to each tablet.Additionally, a picture 2568 of each tablet is provided and the dosageconcentration 2570 is provided for each medication. Information aboutthe associated generic drug 2572 is also provided. Furthermore, anexpiration date may also be provided for each tablet or for eachprescription. Further still, information regarding the generic ortrademarked name of the medication may be provided, manufacturerinformation, corresponding “expiration dates,” personal contactinformation, physician contact information, insurance information, andother such information associated with the tablets in each container.

Further yet, a bar code 2574 provides a means for associating themedications in the foldable box with a particular patient. Alternativemeans for associating the medications in the box to the patient include,by way of example but not of limitation, the patient's name, a serialnumber, a radio frequency identification (RFID) tag, or any other suchmethod for associating an individual with a particular item.

Integrated labeling may also include a Patient Information Booklet thatincludes a plurality of information relating to the patient'sprescription order. The Patient Information Booklet may include specificinformation regarding the medications that a patient is taking, and mayalso include information specific to the patient, including informationabout the disease(s) for which the patient is being treated, orinformation about the mechanism of one or more drugs in the order as itpertains to the specific patient.

Referring now to FIG. 26, an illustrative GUI 2600 is shown. Visible inthe display window 2601 is a portion of the drug summary that willappear in the patient information booklet that is associated with apatient's prescription order. The patient name 2602 appears near the topof the summary page. Illustrative drug descriptions 2604 and 2606include information such as drug name 2608, dosage 2610, dosage form2612, quantity 2614, administration information 2616, number of refills2618, expiration date 2620, prescriber name 2622, and prescriptionnumber 2624.

The inspection process must be performed at about the same time as thelabeling and filling processes. The inspection not only verifies thateach prescription in the order is correctly filled; it also verifiesthat the labeling information is correct and is correctly associatedwith the appropriate patient and prescription order. Further, since theprescription order will typically be dispensed in a compliance containersimilar to those described above, the labeling information must alsoaccurately reflect the time period for administration of each drug.Further still, the integrated labeling must also accurately reflect thepatient information. All of this information must be confirmed duringthe inspection process.

One embodiment of the inspection process is shown in the illustrativeflowchart of method 2700 in FIG. 27. At block 2702, the inspectionprocess is initiated by scanning a bar code of the label affixed to anystrip, after the inspection tab is selected in EPPA. The inspectionprocess includes an initial inspection, which is a secondary validationof drug name, strength, directions, and patient name, at block 2704. Themethod then proceeds to decision diamond 2706, where it is determined ifall information is correct. If any of the information is incorrect, themethod proceeds to block 2744, where the package is removed from theinspection process and placed into the package recovery process.

If the information is correct, the method proceeds to block 2708, wherethe approval of each prescription individually and of the entireprescription order takes place. The method then proceeds to block 2710,where any strip in the order is scanned and the patient's name isverified. Moving on to decision diamond 2712, if the patient's name isnot correct, the method proceeds to block 2744, where the package isremoved from the inspection process and placed into the package recoveryprocess.

If the patient's name is correct, the method proceeds to block 2714,where a visual inspection takes place to verify that each pouch or cupholds the correct number of tablets. Moving on to decision diamond 2716,if the number of tablets is not correct, the method proceeds to block2744, where the package is removed from the inspection process andplaced into the package recovery process. The visual inspection mayinclude visual inspection by a qualified operator, machine-visiontechniques, or some combination thereof.

If the number of tablets in each pouch or cup is correct at decisiondiamond 2716, the method proceeds to block 2718, where each type oftablet that appears in the pouches or cups is matched to a portion ofits integrated labeling, verifying that the tablets are the correct onesthat correspond to the prescription order. Moving on to decision diamond2720, if one or more tablet imprints do not match, the method proceedsto block 2744, where the package is removed from the inspection processand placed into the package recovery process.

If the tablet imprints match, the method proceeds to block 2722, wherethe quantity of each tablet type in each cup or pouch is verified.Moving on to decision diamond 2724, if one or more cups or pouches donot contain the correct quantity of each tablet, the method proceeds toblock 2744, where the package is removed from the inspection process andplaced into the package recovery process.

If the quantities of each drug tablet in each pouch or cup are correct,the method proceeds to block 2726, where the information on theintegrated labeling is verified, and the print quality is confirmed tobe good. Moving on to decision diamond 2728, if any label information isincorrect, or if the print quality is unacceptable, the method proceedsto block 2744, where the package is removed from the inspection processand placed into the package recovery process.

If the integrated label information is correct and the label informationis determined to be of sufficient print quality, the method proceeds toblock 2730, where the inspected strip is accepted. The method thenproceeds to decision diamond 2732, where it is determined if there areadditional strips to process for the prescription order. If there areadditional strips to process, the method returns to block 2710, and eachadditional strip is processed in the manner described above, from block2710 to decision diamond 2732.

Once there are no more strips to process at decision diamond 2732, themethod proceeds to block 2734, where the labels are affixed to thesecondary containers, and to the pouches or cups if necessary. Themethod then proceeds to block 2736, where all items are placed in a totefor further processing, including folding, loading, and/or sealing, asnecessary.

The method then proceeds to block 2738, where the handwrittenprescription is initialed by a qualified pharmacist. The method thenproceeds to block 2740, where the initialed handwritten prescriptionscorresponding to the prescription order are filed. The method thenproceeds to block 2742, where the tote assembly is forwarded to theboxing station.

The inspection method described above is illustrative and may vary as todetails. For example, instead of inspecting each strip one at a timebefore strips are forwarded to the boxing station, as described above inthe method 2700, the qualified pharmacist may instead box each strip assoon as the label is verified, and then place the box into the shippingcontainer. Likewise, the qualified Pharmacist may place the strip into aspiral package or into another type of compliance container or apparatusinstead of a box.

Alternatively, the inspection method may include printing the exteriorintegrated labeling that is subsequently affixed to the box before thestrips are approved, but after the order has been verified. Then, thestrip inspection takes place, and each strip is matched to theintegrated label associated with each box as the strip itself isverified.

What is claimed is:
 1. A system for integrating and labeling a pluralityof tablet orders, comprising: a graphical user interface configured to:receive a first input for a first plurality of tablets associated with aparticular patient; and receive a second input for a second plurality oftablets associated with the particular patient; a software moduleconfigured to compile the first input and the second input into anintegrated order; and an integrated label coupled to a packagecontaining a first dose from the first plurality of tablets and a seconddose from the second plurality of tablets, the integrated labelindicating information about the first dose and the second dose.
 2. Theintegrated label of claim 1, wherein the integrated label indicates atime at which the first dose and the second dose are to be consumed. 3.The integrated label of claim 1, wherein the integrated label furthercomprises color images of a tablet from the first dose and a tablet fromthe second dose.
 4. The integrated label of claim 1, wherein theintegrated label further comprises a date on which consumption of thefirst plurality of tablets and the second plurality of tablets is tobegin.
 5. The integrated label of claim 1, wherein the integrated labelfurther comprises large print text.
 6. The integrated label of claim 1,wherein the integrated label further comprises a photograph of thepatient.
 7. The integrated label of claim 1, wherein the integratedlabel further comprises drug precaution information corresponding to oneor more of the tablets contained in the package.
 8. The integrated labelof claim 1, wherein the integrated label further comprises informationabout potential interactions between one or more of the tabletscontained in the package and another substance.
 9. A system forintegrating and labeling a plurality of tablet orders, comprising: agraphical user interface configured to: receive a first input for afirst plurality of tablets associated with a particular patient; andreceive a second input for a second plurality of tablets associated withthe particular patient; a software module configured to compile thefirst input and the second input into an integrated order; an integratedlabel coupled to a package containing a first dose from the firstplurality of tablets and a second dose from the second plurality oftablets; and a secondary container configured to contain a plurality ofpackages, the secondary container comprising a secondary label.
 10. Thesecondary label of claim 9, wherein the secondary label indicatesinformation comprising a time at which the first dose and the seconddose are to be consumed.
 11. The secondary label of claim 9, wherein thesecondary label indicates a date on which consumption of the firstplurality of tablets and the second plurality of tablets is to begin.12. The integrated label of claim 9, wherein the integrated labelfurther comprises color images of a tablet from the first dose and atablet from the second dose.
 13. The integrated label of claim 9,wherein the integrated label further comprises a date on whichconsumption of the first plurality of tablets and the second pluralityof tablets is to begin.
 14. The integrated label of claim 9, wherein theintegrated label further comprises large print text.
 15. The integratedlabel of claim 9, wherein the integrated label further comprises aphotograph of the patient.
 16. The integrated label of claim 9, whereinthe integrated label further comprises drug precaution informationcorresponding to one or more of the tablets contained in the package.17. The integrated label of claim 9, wherein the integrated labelfurther comprises information about potential interactions between oneor more of the tablets contained in the package and another substance.18. A method for integrating and labeling a plurality of tablet orders,comprising: receiving with a graphical user interface: a first input fora first plurality of tablets associated with a particular patient; and asecond input for a second plurality of tablets associated with aparticular patient; compiling with a software module the first input andthe second input into an integrated order; generating with the softwaremodule an integrated label to couple to a package containing a firstdose from the first plurality of tablets and a second dose from thesecond plurality of tablets, the integrated label indicating informationabout the first dose and the second dose.
 19. The method of claim 18,further comprising generating with the software module a secondary labelfor a secondary container containing a plurality of packages.
 20. Themethod of claim 19, wherein the secondary label indicates informationcomprising a time at which the first dose and the second dose are to beconsumed.
 21. The method of claim 19, wherein the secondary labelindicates a date on which consumption of the first plurality of tabletsand the second plurality of tablets is to begin.